Are the New FDA Deeming Regulations Stifling Innovation?

The FDA deeming rules may seriously harm the e-cigarette industry, which may, in turn, be harmful to public health.

Nicopure Labs, a manufacturer of e-cigarette liquid, has challenged the FDA’s new regulation of e-cigarettes, and TechFreedom and the National Center for Public Policy Research have now filed an amicus brief in support of the challenge.

In May, the FDA finalized its Deeming Rule regulations, which would force e-cigarette manufacturers to undergo an expensive and time-consuming premarket tobacco application process unless their products were on the market — or substantially equivalent to a product on the market — prior to the predicate date of February 15, 2007, long before modern e-cigarettes were introduced. The high cost of the application process means most e-cigarette businesses will be forced to shut down, eliminating choices of dramatically safer alternatives to combustible cigarettes, which will leave smokers with fewer options to compete against the most harmful form of nicotine consumption, combustible tobacco.

The brief concludes:

The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.

“This is an absurd way to regulate new technology,” said Evan Swarztrauber, communications director at TechFreedom. “The e-cigarette industry looks nothing like it did in 2007, and setting the most primitive products as a baseline for regulatory approval is the best way to stifle innovation. The FDA’s obsession with perfect safety will deny Americans what is obviously a safer technology for consuming nicotine — 95% safer than smoking tobacco, according to Public Health England. The FDA has simply ignored such data, giving essentially zero weight to the benefits smokers and the general public.”

“Instead of developing science-based standards which would reduce harm, the FDA directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes,” said Jeff Stier, senior fellow at the National Center for Public Policy Research. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress.”

“Regulations should be promulgated within the constraints of the rule of law, sound policy and proportionality,” said Daniel Suraci, an attorney working pro bono on behalf of the National Center for Public Policy Research. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer-causing tobacco products.”